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Ramipril |
Altace |
Clinical Trial: Angiotensin-II Blockade in Mitral Regurgitation
This study is currently recruiting patients.
Purpose
To compare two angiotensin-II blockade drug treatments for the treatment of organic mitral regurgitation.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Heart Diseases Mitral Valve Insufficiency | Drug: Candesartan Drug: Ramipril | Phase III |
MedlinePlus related topics: Heart Diseases; Heart Diseases--Prevention; Heart Valve Diseases
Study Type: Interventional
Study Design: Randomized, Double-Blind, Placebo Control
Study start: April 2001; Expected completion: March 2005
BACKGROUND: Mitral regurgitation (MR) is frequent and its prevalence is increasing with aging of the population. Organic MR, due to primary valvular lesions has severe consequences determined by its degree, with left ventricular (LV) remodeling and dysfunction, left atrial (LA) enlargement, leading to poor clinical outcome. Surgery can eliminate MR, but carries notable risks and is not applicable to all patients. Therefore, chronically decreasing MR, protecting LV and LA with vasoactive treatment are major goals of medical therapy. However, effects of chronic oral vasoactive treatment of MR are controversial and uncertain and recent practice guidelines underscored these gaps in knowledge and did not recommend vasoactive treatment of MR. Hence, a trial of treatment of organic MR is needed.
DESIGN NARRATIVE: A randomized clinical trial, placebo controlled, double-blind, without crossover, of one year oral treatment with potent tissue angiotensin blockade (with one arm using Candesartan [an angiotensin-II receptor antagonist] and one arm using Ramipril [a tissue angiotensin converting enzyme inhibitor] ) titrated to the maximally tolerated dose. The trial is preceded by an acute study to determine tolerance. End-points are measured by Doppler-Echocardiography for quantitation of MR (regurgitant volume) using a combination of three simultaneous methods (quantitative Doppler, two-dimensional echocardiography, proximal flow convergence) and combination of echocardiography and electron beam computed tomography for left ventricular and left atrial volume measurement. This single center study seeks to enroll a total of 135 patients. The analysis will be based on intention to treat and compares changes in regurgitant volume, left ventricular end-diastolic volume index and left atrial volume measured after one year of treatment with active drugs or placebo.
Eligibility
Ages Eligible for Study: 21 Years - 80 Years, Genders Eligible for Study: Both
Criteria
Location and Contact Information
Minnesota
Mayo Clinic Foundation, Rochester, Minnesota, 55905, United States; Recruiting
Maurice Enriquez-Sarano, Study Chair
Maurice Enriquez-Sarano, Mayo Clinic Foundation
More Information
Publications
Thomson HL, Basmadjian AJ, Rainbird AJ, Razavi M, Avierinos JF, Pellikka PA, Bailey KR, Breen JF, Enriquez-Sarano M. Contrast echocardiography improves the accuracy and reproducibility of left ventricular remodeling measurements: a prospective, randomly assigned, blinded study. J Am Coll Cardiol. 2001 Sep;38(3):867-75.
Avierinos JF, Brown RD, Foley DA, Nkomo V, Petty GW, Scott C, Enriquez-Sarano M. Cerebral Ischemic Events After Diagnosis of Mitral Valve Prolapse. A Community-Based Study of Incidence and Predictive Factors. Stroke. 2003 May 8 [epub ahead of print]
Record last reviewed: December 2004
Last Updated: January 10, 2005
Record first received: April 11, 2001
ClinicalTrials.gov Identifier: NCT00014846
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
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